Blister-type packaging is one of the more common forms of packaging for solid pharmaceutical dosage forms, particularly in Europe where blister-type packaging is more common. Also, blister packaging is used for certain dosage forms that cannot be exposed for any length of time to either moisture or light, or where the dosage form can be easily damaged.
In particular, blister-type packaging consists of a lower portion or “tray” which comprises a series of separate, spaced apart recesses. Each recess is sized to be slightly larger than the solid dosage form. Each recess typically receives a single dosage form. The solid pharmaceutical dosage forms are then protected within the recess by sealing the exposed or upper portion of the tray with a sheet in whole or in part.
The sheet may include metal, such as aluminum, depending on the extent of protection needed by the particular solid pharmaceutical dosage form. The sealing is typically a heat sealing process. The sealing of the sheet onto the tray is designed to prevent moisture and light from getting into the recess. Proper storage of solid dosage forms such as tablets and capsules is important in maintaining a level of quality for the stored product through the determined shelf life. If moisture and/or light get through to the dosage form, the shelf life of the dosage form may be significantly compromised, and the quality of the dosage form may be detrimentally effected. If this happens, the safety and/or efficacy of the dosage form may be compromised.
At present, the type of blister packs that require metallic laminates require a thick layer of the metal (in the range of 15 to 60 microns) to be effective. With this thickness, it then becomes difficult for the user to easily remove the tablet or capsule without damaging the tablet or capsule in the process in situations where the tablet or capsule is pushed through the aluminum layer. Thus, at present, many of existing metallic foil blister pack designs which effectively seal against moisture require the use of scissors to remove the metallic laminate seal from the recess in order to access the tablet or capsule. Patients having limited dexterity or strength, may not be able to safely remove the dosage form from the seal without significant risk to their safety. Moreover, even with the use of scissors or another sharp object, removal of the tablet or capsules intact also becomes a problem. Many tablets or capsules are not effective if taken when damaged. In addition, a scissors or knife or other sharp object is not always available for use, for example during air travel.
In addition to the thick metal layer, blister-type packaging at present often times requires the separation of the lower portion or tray into smaller subsections in order to access a tab or an unsealed edge from which to peel off the sealed layer. Again, the separation of the tray into subsections may cause damage to the dosage forms contained therein or result in an unintentional opening of one or more recesses during the separation process. Moreover, it may be difficult or impossible for patients with limited dexterity or strength to separate the tray into the subsections.
A further limitation on the blister-type packaging of today involves the location of the unsealed area of the sheet. Many of the present designs do not provide a tab or free end that is easily accessible for all patients, including those with limited dexterity. Many of the present designs require a sufficient amount of agility to easily peel away the free area.
Thus, there is a need for an effective laminate seal against moisture and/or light that may be safely and manually removed by the user, including those having limited dexterity.
There is a further need for a blister pack having an easy means of removing the seal which will enable patients with limited dexterity to remove the seal without damaging the contents.
There is also a further need for a blister pack design that does not require physical separation of the blister compartments prior to removal of the seal.